TAKA ANEURYSM CLIP by V. MUELLER NEURO/SPINE

I am sorry, but the provided text from the FDA document (K972750) is a 510(k) clearance letter for the Taka Aneurysm Clip. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device and is generally focused on regulatory approval rather than detailed performance study reports.

The document does not contain the information necessary to answer your request about acceptance criteria and the specifics of a study proving device performance, such as:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
Information on Multi-Reader Multi-Case (MRMC) studies or any effect sizes.
Details about standalone algorithm performance.
The type of ground truth used (pathology, outcomes data, etc.), or how it was established.
Sample size for training sets.

The letter primarily covers:

Confirmation of device clearance (K972750).
Device name: Taka Aneurysm Clip.
Regulation details (21 CFR 882.5200, Aneurysm clip, Class II).
Indications for Use: Temporary occlusion of intracranial blood vessels/aneurysms, and permanent placement in the brain for occlusion of aneurysms.

To find the kind of detailed study information you're asking for, you would typically need to consult a different part of the 510(k) submission, such as the full premarket notification, or scientific publications related to the device, which are not included in this FDA clearance letter.

Summary

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NOV 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pacific Surgical Innovations, Inc. % Mr. Terry Johnston President 360 Industrial Road, Unit H San Carlos, California 94070

Re: K972750

Trade/Device Name: Taka Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: June 8, 1998 Received: June 15, 1998

Dear Mr. Johnston:

This letter corrects our substantially equivalent letter of July 9, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or fo devices that have been reclassified in accordance with the provisions of the Federal Foend. Orug and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). 701 may, therefore, market the device, subject to the general controls provisions of the Act. The goneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, PTDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eestronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000- 050.

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Page 2 - Mr. Terry Johnston

This letter will allow you to continue marketing your device as described in your Section 510(k) I mis lotter will anon yourse FDA finding of substantial equivalence of your device to a legally premailer notificated on " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you doon o office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely you

for Pts. Thoms Das Dastgul

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972750

SECTION 5 INDICATIONS FOR USE

510(K) Number:

K972750

Device Name:

Taka (Tm) Aneurysm Clip

Indications for Use:

Temporary occlusion of intracranial blood verssels/aneurysms.

Permanent placement in the brain for occlusion of aneurysms.

rdiovascular, Respiratory, rological Devices 972750

Prescription Use

Over the Counter _____________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 882.5200 Aneurysm clip.

(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).